MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LARGE STYLE VENTRICULAR CATHETER SET; N/A

Catalog Number INS4500

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/08/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the evd fractured upon removal from a (b)(6) female patient.The surgeon left the fractured part of the ins4500 in the patient.There was no patient injury reported.The patient was getting a shunt inserted weeks later and after a ct of the patient¿s head was taken, the fractured part of the product was identified.As the doctor implanted the shunt, he was able to retrieve the fractured part of the ins4500 as a byproduct of the shunt placement.The doctor said that the fracture of ins4500 was not related to the tubing or the product itself.The doctor believes that the fracture of the product was directly related to the bony prominence that existed in the skull.

Manufacturer Narrative

Investigation completed 01/12/2018.Event and non-conformance logs were reviewed for the mentioned lot and did not reveal anything that could cause the reported event.No events and/or rework were recorded for the mentioned lot.Lot number: 1170832.Catalog number: ins4500.Manufacturing date: march 21, 2017.The client reported that the sample and three (3) others they had in stock were "discarded." no other complaints have been received for lot 1170832.It is not clear if this happened during insertion where it may have been pulled back to redirect or retarget or if it was being removed sometime after implantation.If during implantation procedure, the ifu provides the following warning: ¿to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guide wire if used) must be removed simultaneously.¿ according to the attending doctor¿s expert opinion, ¿the fracture of ins 4500 was not related to the tubing or the product itself.He believes that the fracture of the product was directly related to the bony prominence that existed in the skull.¿ the most probable cause for this event is related to the bony prominence that existed in the patient¿s skull as stated by the attending doctor.

Manufacturer Narrative

The device history record review of reported lot did not reveal any deviation/anomalies that could cause the reported condition.No event was generated for the mentioned lot; therefore, the lot complied with all in-process inspections and testing requirements as specified in the manufacturing shop order and related procedures.(b)(4).

Event Description

N/a.

• Brand Name: HERMETIC LARGE STYLE VENTRICULAR CATHETER SET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7113708
• MDR Text Key: 94737424
• Report Number: 2648988-2017-00053
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K961113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: INS4500
• Device Lot Number: 1170832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR